MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number A2025-060

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 clarifier- incorrect prep.

Event Description

It was reported that the procedure was to treat a moderately calcified, mildly tortuous peroneal artery that is 80% stenosed.The 2.5x60mm armada 14 balloon catheter was not air aspirated outside the anatomy prior to use.Once at the lesion, the balloon would not hold pressure after inflation to nominal pressure and was noted to be deflating.However, balloon angioplasty was completed with the same armada and then the device was removed.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.

• Brand Name: ARMADA 14 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19033495
• MDR Text Key: 339259402
• Report Number: 2024168-2024-04164
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08717648156021
• UDI-Public: (01)08717648156021(17)260630(10)3012341
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2025-060
• Device Lot Number: 3012341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1